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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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The utilization of minimally invasive techniques has brought about a transformative shift in the approach to face rejuvenation, potentially representing one of the most notable advancements in facial plastic surgery in recent times. Originally employed to address the presence of fine lines and wrinkles, the application of fillers has now evolved to encompass the remediation of volume depletion and the enhancement of the aging visage.
Over a period of time, the convex shape of the midface region has the potential to undergo a flattening or concave transformation.
KOS® M in the dermis regulates water balance, osmotic pressure and ion flow and functions as a sieve, excluding certain molecules, enhancing the extracellular domain of cell surfaces and stabilizes skin structures by electrostatic interactions.
The Research Question of the present study is the following: to collect sufficient clinical data to demonstrate compliance with the General Safety and Performance Requirements of KOS® M when used as intended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KOS® M | Other | An open, non-comparative, interventional single-armed clinical trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KOS® M | Device | Delivery of medical device as injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of KOS® M in lip augmentation | The primary objective of the study is to evaluate the effectiveness of KOS® M in lip augmentation by assessing changes in the Allergan Lip Fullness Scale (ALFS). Response is defined as a ≥1 point improvement in ALFS at 3 months after last treatment. Allergan Lip Fullness Scale - from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness on KOS® M in lip augmentation | Effectiveness on KOS® M in lip augmentation through the assessment of the change in ALFS Allergan Lip Fullness Scale - from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Behnam D Bayatani | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Beyond Dental | Timișoara | Timiș County | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25763894 | Background | Attenello NH, Maas CS. Injectable fillers: review of material and properties. Facial Plast Surg. 2015 Feb;31(1):29-34. doi: 10.1055/s-0035-1544924. Epub 2015 Mar 12. | |
| 25805282 | Background | Werschler WP, Fagien S, Thomas J, Paradkar-Mitragotri D, Rotunda A, Beddingfield FC 3rd. Development and validation of a photographic scale for assessment of lip fullness. Aesthet Surg J. 2015 Mar;35(3):294-307. doi: 10.1093/asj/sju025. |
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| Effectiveness on KOS® M in lip augmentation |
Effectiveness on KOS® M in lip augmentation through the assessment of the change in FACE-Q Satisfaction with lips FACE-Q Satisfaction with lips - from 1 (Very Dissatisfied) to 4 (Very satisfied) |
| 3 months |
| Effectiveness on KOS® M in lip augmentation | Effectiveness on KOS® M in lip augmentation through the assessment of the change in GAIS GAIS-The global aesthetic improvement scale - from 1 (very much improved) to 5 (worse) | 3 months |
| Change in the ALFS (Allergan Lip Fullness Scale) Grade from baseline | Change in the ALFS (Allergan Lip Fullness Scale) Grade from baseline at 1, 3, 6 and 12 months after the last treatment. Allergan Lip Fullness Scale - grade from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout) | 1, 3, 6 and 12 months |
| Proportion of participants with at least 1-point improvement from baseline on the ALFS | Proportion of participants with at least 1-point improvement from baseline on the ALFS at 1,6 and 12 months after the last treatment (response rates) Allergan Lip Fullness Scale - grade from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout) | 1,6 and 12 months |
| Change from baseline in FACE-Q Satisfaction with Lips scores | Change from baseline in FACE-Q Satisfaction with Lips scores at 1, 3, 6 and 12 months after the last treatment. FACE-Q Satisfaction with Lips scores - from 1 (Very Dissatisfied) to 4 (Very satisfied) | 1, 3, 6 and 12 months |
| Proportion of participants having a positive aesthetic evolution on the 5-point Global Aesthetic Improvement Scale (GAIS) | Proportion of participants having a positive aesthetic evolution on the 5-point Global Aesthetic Improvement Scale (GAIS) evaluated by the physician and subject on the lips at 1, 3, 6 and 12 months after the last treatment GAIS (The Global Aesthetic Improvement Scale) - from 1 (Very much improved) to 5 (worse) | 1, 3, 6 and 12 months |
| 26618456 | Background | Dayan S, Bruce S, Kilmer S, Dover JS, Downie JB, Taylor SC, Skorupa A, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation. Dermatol Surg. 2015 Dec;41 Suppl 1:S293-301. doi: 10.1097/DSS.0000000000000540. |